{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA089424"
        ],
        "brand_name": [
          "SPIRONOLACTONE"
        ],
        "generic_name": [
          "SPIRONOLACTONE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "53489-143",
          "53489-328",
          "53489-329"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SPIRONOLACTONE"
        ],
        "rxcui": [
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          "198223",
          "313096"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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          "53489-143-05",
          "53489-143-10",
          "53489-328-07",
          "53489-328-02",
          "53489-328-06",
          "53489-328-01",
          "53489-328-03",
          "53489-328-05",
          "53489-328-10",
          "53489-329-07",
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          "53489-329-06",
          "53489-329-01",
          "53489-329-03",
          "53489-329-05",
          "53489-329-10"
        ],
        "is_original_packager": [
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        "upc": [
          "0353489143011",
          "0353489329019"
        ],
        "nui": [
          "N0000175557",
          "N0000011310"
        ],
        "pharm_class_epc": [
          "Aldosterone Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Aldosterone Antagonists [MoA]"
        ],
        "unii": [
          "27O7W4T232"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97391",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0574-2025",
      "product_description": "Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01",
      "product_quantity": "11,328 bottles",
      "reason_for_recall": "Presence of foreign substance: identified as aluminum.",
      "recall_initiation_date": "20250805",
      "center_classification_date": "20250807",
      "report_date": "20250813",
      "code_info": "Lot # P3314, Exp 11/30/2026",
      "more_code_info": ""
    }
  ]
}